Purpose :
Latanoprostene bunod (LBN) is a nitric oxide-donating prostaglandin F2α analogue in development for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). Studies have shown that the risk of glaucoma onset and progression is attenuated by lowering IOP. We evaluated the long-term safety and efficacy of LBN ophthalmic solution 0.024% in open-label trial conducted in Japanese subjects with OAG or OHT.

Methods :
This was a phase 3, single-arm, multicenter, open-label study. Japanese subjects ≥20 years of age with OAG or OHT and a mean IOP of ≥ 15 mm Hg and ≤ 36 mm Hg in 1 or both eyes were enrolled. Subjects instilled 1 drop of LBN ophthalmic solution 0.024% qPM in the affected eye(s) over a 1-year treatment period. Absolute values for IOP and changes from baseline were determined every 4 weeks at 10 am (13 on-treatment visits). Safety assessments included vital signs, comprehensive ophthalmic exams, and treatment-emergent adverse events (TEAEs).

Results :
Of 130 randomized subjects, 121 completed the study. Mean (SD) IOP at baseline was 19.6 (2.9) mm Hg (study eye). There was a 22.0% reduction from baseline in IOP to 15.3 (3.0) mm Hg at the first follow-up visit (Week 4), and that reduction was sustained over the 1-year treatment period, with a 26.3% reduction from baseline to 14.4 (2.7) mm Hg at the final Week 52 visit. Reductions from baseline (range: 4.3-5.3 mm Hg) were significant at all 13 time points (P<0.001). Ocular TEAEs were reported in 58.5% of subjects (study eye). Common TEAEs included conjunctival hyperemia (17.7%), growth of eyelashes (16.2%), eye irritation (11.5%), eye pain (10.0%), iris hyperpigmentation (3.8%), and blepharal pigmentation (3.1%). No safety concerns were raised as a result of any of the ocular sign assessments or vital sign measurements.

Conclusions :
Results from this 1-year study demonstrate that LBN 0.024% qPM was safe and well tolerated and provided robust and sustained long-term IOP lowering in Japanese subjects with OAG or OHT.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.